The provided text is a 510(k) Summary submission for the AMS Apogee™ Vault Suspension System. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing a specific study to prove the device meets pre-defined acceptance criteria with performance metrics.

Therefore, many of the requested sections (Table of acceptance criteria and reported device performance, sample size, data provenance, number of experts, adjudication method, MRMC study, effect size, standalone performance, type of ground truth for test set, training set details) cannot be fully populated from the provided text.

Here's an attempt to answer based only on the information available in the given text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or reported device performance metrics in numerical terms. Instead, it states: "The mesh used in the Apogee™ Vault Suspension System has been tested in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh and has been shown to be equivalent to the listed predicate devices. In addition, the other components have demonstrated substantial equivalence to the predicate devices in terms of mechanical performance and biocompatibility."

This implies that the acceptance criteria revolved around demonstrating equivalence to predicate devices in the following areas:

Acceptance Criteria	Reported Device Performance
Equivalence to predicate devices for surgical mesh in accordance with FDA guidance.	"has been shown to be equivalent to the listed predicate devices."
Substantial equivalence in mechanical performance for other components.	"have demonstrated substantial equivalence to the predicate devices in terms of mechanical performance."
Substantial equivalence in biocompatibility for other components.	"have demonstrated substantial equivalence to the predicate devices in terms of ... biocompatibility."

2. Sample sized used for the test set and the data provenance

Not provided in the document. The text mentions "tested," but no details about the sample sizes or the nature (retrospective/prospective, country of origin) of the data, if any clinical data was involved. The testing appears to be primarily bench or material-based to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The provided text describes tests for material equivalence and mechanical performance, not diagnostic performance requiring expert interpretation or ground truth establishment in a clinical context.

4. Adjudication method for the test set

Not applicable. This concept applies to studies involving human interpretation or clinical endpoints, which are not detailed here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device, not an AI or imaging diagnostic device where MRMC studies are typical.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an AI or imaging diagnostic algorithm.

7. The type of ground truth used

For the mesh, the ground truth was established by adherence to "FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh" and its comparison to the characteristics of the predicate devices. For other components, ground truth for mechanical performance and biocompatibility would be based on established engineering standards and biological safety assessments, again likely benchmarked against predicate devices. No specific "ground truth" in the clinical sense (e.g., pathology, outcomes data) is mentioned as being directly used in this summary.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model where a training set would be relevant.

9. How the ground truth for the training set was established

Not applicable (as above).

Summary

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APR 2 2 2004

page 4/2

510(k) Summary AMS Apogee™ Vault Suspension System KO4053

510(k) Number

Date of Summary Preparation: March 1, 2003

Submitter/Contact Person:

Elsa A. Linke Regulatory Affairs Specialist American Medical Systems 10700 Bren Rd. W Minnetonka, MN 55343

Phone: (952) 930-6000 Fax: (952) 930-6496

Device Name and Classification:

Trade Name: AMS Apogee™ Vault Suspension System Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh, polymeric Product Code: OTP Classification: Class II

Manufacturing Location:

American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343

Predicate Devices:

AMS Sparc Sling System - K011251, K013355, K020663 AMS Monarc Sling System - K023516 AMS BioArc - K030123 AMS Large Pore Polypropylene Mesh - K033636 IVS Tunneller - K010035

Indications for Use:

The Apoqee™ Vault Suspension System is intended for use in vaginal vault suspension to treat pelvic organ prolapse.

Device Description:

The Apogee™ Vault Suspension System consists of needles and connectors used to pass a polypropylene mesh for support of the vaginal vault.

Summary of Testing

The mesh used in the Apogee™ Vault Suspension System has been tested in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh and has been shown to be equivalent to the listed predicate devices. In addition, the other components have demonstrated

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K040537 page 2/2

substantial equivalence to the predicate devices in terms of mechanical performance and biocompatibility.

1. 11

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The logo is simple and recognizable, and it is often used on official documents and websites.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Elsa A. Linke Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343

SEP 2 8 2012

Re: K040537 Trade/Device Name: Apogee™ Vault Suspension System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: March 1, 2004 Received: March 2, 2004

Dear Ms. Linke:

This letter corrects our substantially equivalent letter of April 22, 2004.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fuchs

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K040537

Device Name: Apogee™ Vault Suspension System

Indications For Use: The Apogee™ Vault Suspension System is intended for use in vaginal vault suspension to treat pelvic organ prolapse.

Prescription Use______________________________________________________________________________________________________________________________________________________________ × (Per 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

iriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.

(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.